Instrument for assisting in the remote placement of tied surgical knots and trimming of suture away from the knot and method of use

ABSTRACT

An instrument ( 10 ) is provided having a shaft ( 12 ) extending to a distal end (16). The distal end ( 16 ) has a distal tip member ( 40 ) having a cavity ( 42, 83 ), and a passageway ( 44, 80 ) extending to the cavity through which a first suture end ( 48 A) of a loop of suture ( 48 ) extends from a tissue site to facilitate a user looping a second suture end ( 48 B) around the first suture end ( 48 A) between the distal tip member ( 40 ) and the tissue site to form a knot (48C). Advancing of the distal tip member ( 40 ) while drawing the first suture end ( 48 A) through the passageway ( 44, 80 ) pushes the knot ( 48 C) for placement at the tissue site. The distal tip member ( 79 ) of another embodiment provides an additional open-sided passageway ( 81 ) through which the second suture end ( 48 B) is passed to assist in forming and pushing a knot at to the tissue site. A more secure knot ( 50 ) may be formed by a double loop ( 49 A) and then a single loop ( 49 B) by the second suture end (48B) around the first suture end ( 48 A) and appropriate tensioning of the first and second suture ends when the knot is pushed to the tissue site. The distal end (16) further has two openings ( 46, 47 ) through which the two suture ends ( 48 A,  4813 ) are passed from the placed knot ( 48 C,  50 ), and a blade ( 38 ) in the distal end ( 16 ) is positionable to cut the two suture ends near the tissue site to trim the suture away from such knot.

This application claims the benefit of priority to U.S. ProvisionalPatent Application No. 60/444,935, filed 4 Feb. 2003, which is hereinincorporated by reference.

FIELD OF THE INVENTION

The present invention relates to an instrument, method, and system forsurgically pushing hand-tied knots down to a wound closure site intissue and then using the same instrument to trim excess suture away.The invention is useful for applying surgical knots to suture at remotelocations in the body of a patient accessible through ports or cannulas.The instrument may also facilitate suture tying as is required forclosing wounds through minimally invasive surgical techniques, such aslaparoscopy, or through a single port, like a nephroscope, for apercutaneous pyeloplasty.

BACKGROUND OF THE INVENTION

A need exists for an improved surgical instrument to enable safer andmore efficacious placement of hand tied knots at remote sites in thebody. The use of suture or strings to aid in closing wounds has beenknown since ancient times. The suture tails left on top of a knot arecut away and removed from the patient in most surgical procedures, sincethey provide no structural function and are made of a material foreignto the body. With the advent of modern imaging technologies that permitsurgical procedures to be conducted through small ports in the patientinstead of through large open incisions, the hand tying of knots,sliding loops down the suture and trimming the suture tails at remotesurgical sites can be quite challenging. Laparoscopically hand tiedknots with conventional knot pushers have surprisingly high failurerates.

Conventional devices for pushing a throw of a knot down to tissuetypically consists of a simple shaft with either a hole or a slot at itsdistal end. The benefits of a hole are that once the one end of thesuture is placed through the hole, it cannot fall out while the sutureis being passed down toward the wound site. However, under laparoscopicconditions, with gloved hands and bodily fluids on sutures, it is oftendifficult to pass the suture through a hole, so the holes in the distalend of many knot pushers are made large to facilitate easier suturepassage during loading. However, holes that are large enough for unaidedeasy suture admittance often let the loop of knot slide through the holewhile the instrument is being passed down towards the wound closuresite. This trapping of the knot loop in the knot pusher hole can attimes be problematic and often interrupts the flow of the knot tyingprocedure. An open slot at the distal end of a knot pusher makes iteasier to load the suture (i.e., a hole does not need to threaded) priorto pushing the knot down, but very often the knot loop slips out of theslot and the loop is not adequately pushed down. The loop must bemanually reloaded into the distal slot and attempt must again be made toslide the loop down to the wound closure site without it releasing fromthe slot.

The cutting of surgical suture at remote sites previously required anadditional instrument, typically a long shafted scissors. The suturescissors often is introduced through a different port than the standardknot pusher. Use of another instrument for cutting suture thus requiresanother step, another port, and can be cumbersome and time consuming. Tooptimize surgical procedure efficacy, such cumbersome and time consumingrepeated instrument exchanges should be minimized. Alternative devicesare available that offer pre-tied knots either as a single closed loop(i.e. like a noose) or as pre-tied knot with one end of suture attachedto a needle. The closed pre-tied (noose) loop does not enable passingthe suture through a wound site, but just rather around available freelyexposed tissue structures and does not offer a suture cutting option.The pre-tied suturing devices with attached needles, such asQuik-Stitch® (PARE Surgical, Inc., Englewood, Colo.) and SutureAssistant® (Ethicon Endo-Surgery, Inc., Cincinnati, Ohio), can betechnically difficult to use, often have questionable knot security andalso do not provide for a way of cutting the suture once the needle andits suture are pulled through the suture loop and the knot is tightened.

Instead of needles attached to pre-tied knots, which can be relativelyawkward and unreliable, specialized suturing instruments, such as theSEW-RIGHT® SR• 5®. (made by LSI SOLUTIONS, Inc., Victor, N.Y.), may beused to accurately place suture prior to requiring knot tying.Technologies do exist to replace the need for hand tying in the form ofthe Ti-KNOTφ device (by LSI SOLUTIONS, Inc., Victor, N.Y.). Instead oftying a knot by hand, this device crimps a piece of metal, typicallytitanium, around the sutures to secure them in place. Leaving behindmetallic foreign materials is sometimes contraindicated under certainconditions. In the case of inside of the kidney's collecting system, aforeign material, such as titanium, may induce the formation of kidneystones. While such alternative surgical knot pushers exist to aid inremote suturing, they do not combine the features for knot pushing alongwith an integrated suture cutting mechanism.

SUMMARY OF THE INVENTION

The principal feature of the present invention is to provide aninstrument, method, and system for facilitating the forming and pushingof surgical tied knots down towards a wound at a remote tissue site, inwhich the same instrument is used for cutting away redundant suturetails.

It is another feature of the present invention is to provide aninstrument, method, and system for facilitating the forming and pushingof surgical tied knots down towards a wound at a remote tissue sitewhich for laproscopic or percutaneous pyeloplasty surgical procedures,where the instrument may be passed through a cannula in the patient or aport of another instrument.

It is still another feature of the present invention to provide animproved method for loading suture through a knot pusher instrumentusing a loop snare tool.

It is a further feature of the present invention to provide an improvedmethod for forming a knot to close a tissue would site using a doubleloop and a single loop of suture.

Briefly described, the present invention embodies an instrument having aproximal end with a housing, a shaft extending from the housing to adistal end to enable remote placement of the distal end in the body of apatient having tissue, such as a wound site, from which a loop of suturewith two ends extends, and a distal tip at the distal end having adistal surface capable of facing the tissue. The distal tip has a holeor opening extending from the distal surface to a cavity in the side ofthe distal tip. A first end of the suture is received through this hole,such as with the assistance of a tool with a snare loop, to enable auser to loop the second end of the suture about the first end of saidsuture to form one or more knots. The distal tip when advanced pushesthese knots as they slide along the first end of the suture to thetissue, while the first end of the suture is being drawn through thehole. Two openings are provided at the distal end through which thefirst and second ends of the suture are received through, such as alsowith assistance of the snare loop tool, after placement of the knots tothe tissue. The distal end has a blade movable from a retracted positionto a forward position to cut (or trim) the suture extending throughthese two openings, in which movement of the blade between its retractedand forward positions is remotely controlled at the housing.

As a safety feature, the slide hole at the distal end of the instrumentused to slide the suture knots to the tissue, and the openings used totrim, are not the same, so that the risk of inadvertently cutting thesuture can be minimized.

A method and system using this instrument is also provided by thepresent invention.

The instrument of the present invention avails itself readily tolaparoscopic procedures using a laparoscope and camera system forvisualization and requiring extracorporeal knot tying through multipleports. For example, in small bowel gastric bypass surgery where multipleknots can be tied adjacent to the jejunum on the small bowel closure,these knots could be tied and slid down using the invention and suturetails readily trimmed. An even more challenging application isillustrated below to show the use of the present invention for knottying through a single port.

The closure of a percutaneous pyeloplasty wound at a stenotic ureteralpelvic junction using only a single nephroscope through which to passinstruments is a very challenging procedure, because traditional suturetying and trimming have been almost unfeasible under nephroscopicconditions. A nephroscope can have a working channel through whichsurgical instruments can be passed. Other technologies are existent thatprovide for the surgical cutting open of the wound (e.g., the CUT-GUIDE™by LSI SOLUTIONS, Inc., Victor, N.Y.) and for the accurate placement ofsuture through the wound prior to tying (e.g., the SEW-RIGHT®SR• 5® byLSI SOLUTIONS, Inc., Victor, N.Y.). Once the suture is placed in a sitelike this through a nephroscope, surgeons often struggle to accuratelytension the suture, appose the wound edges, create the loops that willconstitute the knot and then slide those loops down. Under theseconditions, it is even difficult to get an instrument down to cut suturetails through the single port of a nephroscope.

Once the suture ends have been placed at the appropriate tissue woundclosure site, the instrument of the present invention is passed to thesurgeon. One suture end is placed through a wire snare extending throughthe distal slide hole in the end of the instrument. Using a curvedhandle on the wire snare, the wire snare and the one end of the sutureare pulled through the suture hole at the end of the instrument. At thistime, the wire snare and curved handle are passed off the field. Next, asurgical clamp (e.g., like a mosquito clamp) is put on the end of thesuture that has passed through the hole. Depending on the preference forknot type as chosen by the surgeon, the opposite strand of suture isthen wrapped around the suture that goes through the hole in a fashionknown to make an acceptable surgical knot. Holding both ends of thesuture outside of the body, the instrument is used to slide the loop ofsuture down to the wound closure site. The small suture hole at theinstrument's distal end precludes the knot loop from also slipping intothe suture hole, while sliding the loop towards the closure site; asmooth, contoured surface permitting smooth and unimpeded sliding of theknot down; a cut out or cavity in the distal tip that permits enhancedviewing of the knot within the viewable field of a laparoscope or anephroscope under direct visualization. With the knot of suture now sliddown to the wound closure site, both ends of the suture can be pulledupon to the appropriate tension by the surgeon, thereby accuratelybringing the tissue edges together. The instrument is then slid back upthe cannula with one clamped suture remaining through the suture hole.The next knot loop is then thrown by the surgeon and slid down to beplaced on top of the first knot. This process may be repeated typicallyat least four times, to improve the overall knot security. The clamp isreleased from the one suture end. Both ends of the suture are thenpassed through the two openings at the distal end, thus orienting bothstrands of sutures substantially perpendicular to the length of theshaft at the distal end and in the path of the trimming blade. Theinstrument is then slid back down through the working channel of thenephroscope under direct visualization until the suture tails are at thedesired length to the surgeon's preference. Under appropriate suturetension, the lever is squeezed, actuating the advancement of the suturetrim blade down to the sutures and into a backstop behind the sutures.Both suture strands are completely transected. The lever is releasedpulling the blade back. The instrument is removed from the port alongwith the redundant suture tails. This knot loop tying, sliding andsuture trimming process can be repeated for as many knots as necessarywith the same instrument in the same patient. This invention can be asterile single patient use instrument providing a pristine distal tipfor sliding knots and ensuring a sharp and reliable blade for suturetrimming.

In another embodiment of the present invention, the instrument has adifferent distal tip having two suture receiving passageways, slots oropenings, rather than a single suture receiving hole or openingdescribed above. Each of the passageways extends from the front distalsurface through the distal tip to a different side of the distal tip, inwhich the first end of the suture is extended through a first of thepassageways and then clamped to enable a user to wrap loop the secondend of the suture about the first end in one loop or multiple (e.g.,double) loop of the suture to form one or more knots. The secondpassageway is open along one side of the distal end to receive thesecond end of the suture, in which after the knots are formed the secondend of the suture extending from the second passageway is at leastpartially wrapped around the distal end of the instrument's shaft andclamped when said distal tip is advanced to push the knots along thefirst end of the suture to the tissue, while the first end of the sutureis being drawn through the first passageway. When removed from the firstand second passageways, the ends of the suture may then be placed in theopenings for cutting as described earlier. This method of using theinstrument with the distal tip member of this embodiment is the same asdescribed above, where the first passageway provides the features of thehole in the distal tip member, but when pushing one or more knots, theuse of the two passageways from the distal surface for each of thesuture ends minimizes the risk of premature lock of the knots before thetissue has been appropriately apposed with the knots.

The present invention also provides a method for forming a knot in twoends of suture extending from a tissue wound site by placing a first endof the suture through a hole or passageway along a distal end of aninstrument (such as a conventional knot pusher instrument or theinstrument of the present invention), wrapping the second end of thesuture around the first end of the suture to form a double loop betweenthe distal end of the instrument and the wound site, wrapping the secondend of the suture around the first end of the suture to form a singleloop between the distal end of the instrument and the double loop,pulling the first end of the suture away from the wound site whileadvancing the instrument to push the without tension of the second endof the suture to form a knot from the double loop and the single loopadjacent the wound site, and pulling of the second end of the suture tocause the double loop and the single loop of suture to lock the knotsecurely adjacent the wound site.

The present invention further provides a method for loading suturethrough a hole at the distal end of a conventional knot pusherinstrument, or hole (or passageway) at distal end of the instrument ofpresent invention, by inserting a loop of a snare tool through the holeof the knot pusher, locating one or both ends of the suture through theloop, retracting the loop through the hole, and releasing the end ofsuture from the loop to leave the suture through the hole.

BRIEF DESCRIPTION OF THE DRAWINGS

From the foregoing objects, features and advantages of the inventionwill become more apparent from a reading of the following description inconnection with the accompanying drawings, in which:

FIG. 1 is a perspective view of the instrument of the present inventionwith its lever in the forward position and the suture blade fullyretracted back;

FIG. 1A is an enlarged partial view of the distal end of the instrumentof FIG. 1;

FIG. 2 is a perspective view of the distal end of the instrument of FIG.1 showing the suture snare partially loaded through the suture hole;

FIG. 2A is an enlarged partial view of the distal end of the instrumentof FIG. 2 without suture;

FIG. 3 is a perspective view of the instrument of FIG. 1 with the endsof the suture extended from knots through hole and slot of the distalend;

FIGS. 3A and 3B are different perspective views of the distal end of theinstrument of FIG. 3;

FIG. 4 is a perspective view of the instrument of FIG. 1 insertedthrough the working channel of a nephroscope;

FIG. 5 is a side view of the instrument of FIG. 1 with the right half ofthe instrument's housing removed;

FIG. 6 is an exploded perspective view of the instrument of FIG. 1;

FIG. 7 is a cross-sectional view along lines 7-7 of the instrument ofFIG. 5;

FIG. 8 is a cross-sectional view along lines 8-8 of the instrument ofFIG. 5;

FIG. 9 is a cross-sectional view along lines 9-9 of the instrument ofFIG. 5;

FIG. 10 is a cross-sectional view along lines 10-10 of the instrument ofFIG. 5;

FIG. 11 is a cross-sectional view along lines 11-11 of the instrument ofFIG. 5;

FIG. 12 is a cross-sectional view along lines 12-12 of the instrument ofFIG. 5;

FIG. 13 is a cross-sectional view along lines 13-13 of the instrument ofFIG. 5;

FIG. 14 is a cross-sectional view along lines 14-14 of the instrument ofFIG. 5;

FIG. 15 is a side view of the instrument of FIG. 1 similar to FIG. 5with the handle in the forward position and the blade retracted in thedistal end of the instrument;

FIG. 15A is an exploded partial view of FIG. 15 broken away at thedistal end of the instrument showing suture extending through twoopenings in the distal end prior to being cut;

FIG. 16 is a side view of the instrument of FIG. 1 with the handle beingpulled backwards towards its back position and the blade extended in thedistal end of the instrument;

FIG. 16A is an exploded partial view of FIG. 16 broken away at thedistal end showing which suture extending through two openings at thedistal end is cut by the blade of the instrument;

FIGS. 17-20 are partial perspective views of the distal end of theinstrument of FIG. 1 showing the suture hole receiving one suture endwith the aid of a wire snare loop;

FIGS. 21 and 22 are partial perspective views of the distal end of theinstrument of FIG. 1 showing the suture end partially pulled through thesuture hole with the aid of the wire snare loop of FIGS. 17-20;

FIG. 23 is a partial perspective view of the distal end of theinstrument of FIG. 1 showing one suture end completely through theinstrument's suture hole and now free from the wire snare loop of FIGS.17-22;

FIG. 24 is a partial perspective view of the distal end of theinstrument of FIG. 1 showing one suture end passed through theinstrument's suture hole being clamped;

FIGS. 25 and 26 are partial perspective views of the distal end of theinstrument of FIG. 1 showing the free end of the suture being wrappedwith the first throw of the knot;

FIG. 27 is a partial perspective view of the distal end of theinstrument of FIG. 1 showing the instrument being used to push the knottowards a wound closure site in the tissue;

FIG. 28 is a partial perspective view of the distal end of theinstrument of FIG. 1 showing the knot as it is being slid down to thewound closure site in the tissue;

FIG. 29 is a partial perspective view of the distal end of theinstrument of FIG. 1 showing the curved handle of the suture snare beingintroduced through the two openings at the distal end;

FIG. 30 is a partial perspective view of the distal end of theinstrument of FIG. 1 showing the suture snare of FIG. 29 in place readyto receive suture;

FIG. 31 is a partial perspective view of the distal end of theinstrument of FIG. 1 showing the two end of the suture being loadinginto the suture snare of FIGS. 29 and 30;

FIG. 32 is a partial perspective view of the distal end of theinstrument of FIG. 1 showing the suture now through the trimming holesat the end of the instrument and free from the suture snare of FIGS.29-31;

FIG. 33A is a partial perspective view of the right side of the distalend of another embodiment of the instrument of the present inventionwhich is the same as FIG. 1 except for the distal tip member of theinstrument;

FIG. 33B is a partial perspective view of the left side of the distalend of the instrument in FIG. 33A;

FIG. 34A is a top view of the distal end of the instrument of FIG. 33A;

FIG. 34B is an end view of the distal tip member of the instrument ofFIG. 33A;

FIG. 35A is a right perspective view of the distal tip member of theinstrument of FIG. 33A showing a wire snare placed through the non-opensided slot of the distal tip member;

FIG. 35B is a right perspective view of the distal tip member of theinstrument of FIG. 33A showing a wire snare pulling one end of thesuture back through the non-open sided slot;

FIG. 35C is a right perspective view of the distal tip member of theinstrument of FIG. 33A showing one end of the suture now pulled throughthe non-open sided slot;

FIG. 36A is a right perspective view of the distal tip member of theinstrument of FIG. 33A with a clamp on one end of the suture through thenon-open sided slot and a double loop by the other end of the suturebetween the distal tip member and wound closure site;

FIG. 36B is a right perspective view of the distal tip member of theinstrument of FIG. 33A with a clamp on one end of the suture through thenon-open sided slot and showing an additional loop of suture placedbetween the distal tip member and a double loop;

FIG. 37A is a right perspective view of the distal tip member of theinstrument of FIG. 33A showing one end of the suture from the loopsbeing placed in the open-sided slot of the instrument;

FIG. 37B is a right perspective view of the distal tip member of theinstrument of FIG. 33A showing the suture from the loops in theopen-sided slot and passed under the distal tip member;

FIG. 38A is a right perspective view of the distal tip member of theinstrument of FIG. 33A with a clamp pulling the suture through thenon-open sided slot while the distal tip member guides the loops towardsthe wound closure site;

FIG. 38B is a right perspective view of the distal tip member of theinstrument of FIG. 33A showing the knot now at the wound closure siteand both suture ends simultaneously pulled to secure the knot; and

FIG. 39 is a right perspective view of the distal tip member of theinstrument of FIG. 33A showing the sliding of additional loops of sutureas desired onto the knot to further secure the wound closure site;

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIGS. 1, 1A, and 5-14, the instrument 10 of the presentinvention is shown having a shaft 12 extending from a housing 14 to adistal end 16. The housing is shaped like a pistol having a handleportion 14A, and may be made of a two-piece construction of moldedplastic. Shaft 12 extends from opening 14B of the housing to distal end16. The shaft 12 is provided by a rigid tube 18 (FIGS. 5 and 6) which atits D-shaped end 18A (FIG. 6) is registered into a corresponding shapedopening in an adapter 20, and a threaded nut 23 having an opening whichextends over mounting tube 18 and screws onto the threaded end 21 of theadapter 20. The adapter 20 is mounted by flanges 20A in housing 12. Awasher 31, such as of stainless steel, may be provided over tube 18after nut 31 in housing 14. For example, tube 18 may be stainless steeland have an outer diameter of 5 mm. Shaft 12 may be rigid or flexiblealong all or part of its length to the distal end 16.

The instrument 10 includes an actuator member 22 representing a leverhaving two pins 22A extending into holes 15 in the sides of housing 14upon which the actuator member 22 is pivotally mounted in the housing.Actuator member 22 has a portion which extends through an opening 14C inhousing 14 to enable pivotal movement about pins 22 a. An extensionspring 24 is provided which hooks at one end in a notch 25 of actuatormember 22 and is wound at the other end around a pin 26 located in holes15A in the sides of housing 12, such that the actuator member 22 isspring biased to retain the actuator member normally in a forwardposition, as shown in FIG. 1. The body of housing 14 has a front portion14D providing a stop that limits the pivotal movement of the actuatormember 22. At the top of the actuator member 22 is a slot 27 provided bytwo flanges 28. A drive tube 30 is coupled to the actuator member 22 bya pin 32 received in holes 33 through flanges 28 and through holes 34extending through end 30A of the drive tube 30. The drive tube 30extends into tube 18 through adapter 20, via a bore 20B, and is attachedto a blade driver 36 near the distal end 16 of the instrument 10. Oneend 36A of blade driver 36 has a diameter sized to be received into theopen end 30B of drive tube 30, such that the edge 36B of the bladedriver 36 abuts the edge of open end 30b, and is attached thereto bywelding, brazing, or adhesive. Edge 36 b, and the part of the bladedriver adjacent thereto, has a diameter about the same as the outerdiameter of drive tube 30, but less than the interior diameter of thetube 18. A gasket 37, or rubber ring, is located in an annular recess36C of the blade driver 36 to provide a seal in tube 18 about the bladedriver, but allowing the blade driver to be movable backward or forwardswithin tube 18. A cross-section through the gasket 37, blade driver 30,and tube 18 is shown in FIG. 12. The blade driver 36 extends to itsother end 36B to form a blade 38 having a sharp cutting edge 39. Theblade driver 36 and blade 38 may be of metal, such as stainless steel,and manufactured using electrical discharge machining (EDM) processes. Across section through blade 38 is shown in FIG. 13.

A distal tip member 40 is received into the open end 18B of the tube 18at the distal end of the instrument, and has an end 40A of a diametersized to be received in interior of tube 18 attached thereto by welding,brazing, or adhesive. A cross-section through the distal tip member 40and tube 18 is shown in FIG. 14. The distal tip member 40 has a sideopen cavity 42 having a wall 42A and hole or opening 44 extendingthrough this wall to provide a passageway into the cavity 42. Hole 44 isprovided at the distal tip 40 of the instrument to assist a surgeon inlocating one or more knots into the two free ends 48A and 48B of suture48 which may extend through tissue 49, such as to close a wound intissue of the body of a patient (FIGS. 2 and 2A). The front the wall 42Aprovides a distal surface 42B about hole 44 capable of facing suchtissue when the distal end 16 with distal tip member 40 is located inthe body of the patient. Hole 44 has a diameter which is sized to allowsuture to pass therethrough, but smaller than the diameter of a knotmade with such suture. The edges of wall 42A about hole 44 are smoothand tapered (beveled) to avoid snagging of suture, as shown in FIGS. 1Afor example. A wire loop or snare 45 having a C-shaped handle 45A canpass through hole 44 of the distal tip member 40 (FIGS. 2 and 2A). Oneof the two ends 48A or 48B of suture 48 can be passed through the wireloop 45 (FIG. 2), such that when the wire loop is pulled one of the ends48A or 48B is pulled through hole 44. Distal tip member 40 may be made,for example, of metal or plastic. The operation of the instrument 10 tolocate knots will be describe below in more detail in connection withFIGS. 17-28.

Near open end 18 b, a first opening or hole 46 and a second opening orslot 47 (FIG. 6) is provided in tube 18 through which the two ends 48Aand 48B of loop of suture 48 may be located after knots 48C are placedin the suture, as shown in FIGS. 3, 3A, and 3B. Opening 47 is shown indashed in FIGS. 1 and 1A. Opening 46 may be smaller than opening 47, andopening 47 may extend longer along tube 18 than opening 46 to facilitatedrawing of suture ends 48A and 48B therethrough along the outside ofshaft 12 toward housing 14. As shown in FIGS. 15 and 15A, when retractedin tube 18 by the actuator member 22 being in its forward position, thedrive tube 30 coupled to the actuator member 22 locates the blade 38 ofblade driver 36 behind openings 46 and 47 in the tube 18. As shown inFIGS. 16 and 16A, by pulling the actuator member 22 towards handle 14Aof the housing 14 (as indicated by arrow 19), the drive tube 30 and theblade 38 coupled thereto is advanced forward of the holes 46 and 47(this movement is indicated by arrows 19A,19B, and 19C). Both sutureends 48A and 48B when passed through holes 46 and 47 are substantiallyperpendicular to the length (long axis) of the shaft at the distal end,and in the path of the blade 38. In this manner when suture ends 48A and48B pass into opening 46 and exit opening 47, cutting or trimming ofsuch ends can be achieved near knot(s) 48 c, as shown in FIG. 16A.

Various cross-sectional views of the instrument 10 are provided in FIGS.7-14.

The shaft 12 of the instrument 10 is preferably size to pass through achannel 52 of a shaft 50A of an endoscope, such as nephroscope 50, asshown in FIG. 3. Nephroscope may be a typical nephroscope having anoptical imaging system to view the operation of the instrument 10.However, the instrument may be used with other types of endoscope, orother imaging systems for laparoscopic or other surgical procedures, orwithout an endoscope.

Referring to FIGS. 16, 16A, and 17-32 and, the operation of theinstrument 10 is shown for assisting in forming knots in a loop ofsuture having two free ends extending from tissue and then trimming thefree ends from such knots. As described earlier, a guide loop 45 isfirst passes through hole 44 of the distal tip 40 (FIGS. 17 and 18), andone of the free ends 48B of the suture 48 is passed through the guideloop 45 (FIGS. 19 and 20). The guide loop 45 is then pulled through thehole 44 drawing the free end 48B of suture 48 through hole 44 (FIGS. 21and 22) and the guide loop is removed (FIG. 23). A clamp 52 is thenapplied to the free end of suture 48B (FIG. 24). The other end 48A ofthe suture is looped (e.g., loops 54) around the end 48B of suturebetween hole 44A and the tissue 49 to form a knot 48C (FIGS. 25-27). Theinstrument 10 is then advanced forward, while applying tension on end 48b, i.e., pulling back slightly on the clamped end 48B of the suture,thereby pushing the knot 48C adjacent the tissue 49 (FIG. 28). To placeanother knot, the instrument is pulled back slightly such that the end48A of the suture may again be looped around the end 48B to form anotherknot 48C, and the instrument is similarly advanced to push the knot ontothe tissue 49. When no more additional knots are needed, the clamp 52 isremoved, and the instrument is removed drawing the end 48B of suture outof hole 44. The guide loop 45 is then passed through openings 47 and 46,the two free ends 48A and 48B extending from knot(s) 48C are then passedthrough the guide loop 45, and the guide loop 45 is then retractedthrough openings 46 and 47 drawing the two ends 48A and 48B of suturethrough these openings (FIGS. 29-32). A surgeon holds the free ends 48Aand 48B guides the instrument's distal end 18 adjacent to the site ofthe closed suture, i.e., adjacent the knot(s) 48C made earlier, andwhile applying slight tension on the free ends 48A and 48 b, theactuator member 22 is pulled back advancing the blade 38 and trimmingthe free ends 48A and 48B of suture, as shown in FIGS. 16 and 16A. Theinstrument 10 may then be removed from the body of the patient.

The instrument 10 provides the combination of an optimized remote knotpusher and suture trimming device. The contoured narrow hole 44 forsliding a suture loop of a knot down to a wound closure site, precludingthe suture loop from slipping into the narrow hole and jamming. The wiresnare 45 facilitates loading of the suture through the distal hole 44,conveniently and easily under realistic operating room conditions. Theinstrument 10 also provides a cutaway window or cavity 42 at the distaltip member 40 to enhance knot placement and tying visualization so thatthe suture can be seen both from the side and above throughout the knottying process, such as by an imaging means, such as an endoscope,nephroscope, or the like for viewing distal end 16. To enable suturecutting, this instrument 10 has openings 46 and 47 at distal end 16through which both tails (ends 48A and 48B) of the suture can be passedonce the knot tying is complete. With the suture pulled through theseopenings and under appropriate tension, the actuator member 22 issqueezed to neatly trim off excess suture tails. The instrument 10 alsohas a pistol grip handle with its orientation fixed relative to thedistal end 16, so that the user readily knows where the distal tipmember 40 of the instrument and the hole 44 of the instrument arerelative to the handle. The shaft 12 of the instrument may be passedinto the body of a patient accessible through ports or cannulas, such asused in laproscopic procedures.

Referring to FIGS. 33A-34B, another embodiment of instrument 10 isshown, which is the same as described above, except that the distal endof the instrument has a distal tip member 79 instead of distal tipmember 40. Distal tip member 79 has two suture receiving passagewayslots or openings 80 and 81, rather than a single suture receiving hole44. As best shown in FIGS. 33A, 33B, 34A and 34B, slot 80 extends fromthe distal front surface 79A of the distal tip member 79 to a cavity oropening 83 along the left side of distal tip member 79. Slot 81 extendsfrom surface 79A, and another slot 82 is provided along the top andright side of the distal tip member 79 extending to slot 81, therebyproviding an open sided (or non-circumferentially enclosed) slot,whereas slot 80 is non-open sided (or circumferentially enclosed). Thedistal tip member 79 may be of plastic, or of metal, such as stainlesssteel, and manufactured using electrical discharge machining (EDM)processes. The distal tip member 79 is received in tube 18, similar todistal tip member 40. The diameter of distal tip member 79 mayoptionally increase slightly from its coupling to tube 18 distallytowards end 79A, as illustrated for example in FIG. 34A. In thesefigures, the distal end having the distal tip member of this embodimentis labeled 17. One end of suture 48A or 48B can be received throughopen-sided slot 81, via slot 82, while the other end of the suture canbe received through the non-open sided slot 80. For purposes ofillustration the distal tip member edges are shown relatively straight,however they are preferable smoothed or rounded to avoid damaging tissueor suture.

Referring to FIGS. 35A-38B, end 48A of suture 48 is shown placed throughslot 80 of the distal tip member 79 with the aid of wire snare 45 havinga curved handle 45A. First, wire snare 45 is passed through cavity 83into slot 80 and then exits slot 80 at surface 79A of the distal tipmember 79 (FIG. 35A). Next, by pulling on handle 45A wire loop 45 andits ensnared suture end 48A is drawn back through non-open sided slot 80and cavity 83 (FIG. 35B). Once drawn through slot 80 and cavity 83, thesuture end 48A is released from the wire snare (FIG. 35C) and a clamp 52is placed on that end (FIG. 36A). In FIG. 36A, at a location between thewound site and the distal tip member 79, suture end 48 b is passed twicearound suture end 48A to create a double loop 49A. In FIG. 36B, anadditional single loop 49B of suture end 48B is placed around suture 48Abetween the double loop 49A and the distal tip member 79. Once the loopsare formed, the suture end 48B is received in slot 81 via insertionthrough slot 82 (FIG. 37A). The suture end 48B is now securely in slot81 and then at least partially wrapped around the distal end 17 of shaft12, as shown in FIG. 37B. By pulling on clamp 42 (in direction indicatedby arrow 43), but without tensioning suture end 48B, suture end 48A isdrawn away from the wound 91 in the tissue and loops 49A and 49B arepushed by distal tip member 79 to slid along suture end 48A towards thewound 91 to form a knot at the wound closure site 91 (FIGS. 38A). Theloops are shown loose for purposes of illustration, in actual use theloops are smaller and adjacent to the surface 79A of distal tip member79 between slots 80 and 81. Once the knot is at the wound closure site91, and the tissue edges have been appropriately apposed, pulling onsuture end 48B (in direction indicated by arrow 45), as well as sutureend 48A (in direction indicated by arrow 45A), causes this knot 50 tocinch down and lock a secure enough holding force to enable subsequentknow tying without loss of tissue apposition or knot slippage (FIG.38B). FIG. 39 shows placement of an additional loop 49C on top ofinitial loops to further secure the knot; more additional loops can beplaced as desired. Although this knot is described as being formed withthe add of instrument 10 of this embodiment, this method of tying a knotmay also be used with a conventional knot pusher instrument having ahole or passageway through which one end of the suture from a wound siteis received.

One advantage of this process of constructing a surgical knot is that itpermits the user to place the knot on to the wound closure 91 andappropriately appose the wound edge by pulling only on the clamped endof the suture 48A. Once the correct tissue apposition is achieved, theuser can pull on the free end of the suture 48B to lock the knot 50down. Locking down this initial double loop 49A with single loop 49Balone provides a knot with adequate holding force, at least temporarily,to hold together many types of wound closures. For example, this knotmade with 2-0 STRONGSORB® suture by LSI SOLUTIONS, INC., achieves anaverage tissue holding strengths of approximately 0.5 kg knot holdingforce to temporarily secure and tissue edges together. Subsequent throws(i.e., the single loop 49B) on top of the initial double loop 49A thensingle loop knot will add additional knot holding force up to the nativestrength of the suture (e.g., with 2-0 STRONGSORB®, up to 5 to 6 kgtensile pull). It is believed that no other knot can be constructedunder such surgical conditions and provides excellent tissue holdingforce immediately when the first throws (i.e., the double loop 49A, andthe single loop 49B) are drawn together by pulling on both ends of thesuture.

Once the knots are placed at the wound site, the free ends 48A and 48Bof the suture are removed from slots 80 and 81 by pulling the instrument10 away from the tissue site until the end 48A and 48B exit slots 80 and81. The ends 48A and 48B may then be drawn through openings 46 and 47,and then cut by the instrument 10 similar to that describe earlier.

From the foregoing description, it will be apparent that an instrument,method, and system is provided for assisting remote placement of tiedsurgical knots and trimming of the suture away from the knot. Variationsand modifications in the herein described instrument, method, and systemin accordance with the invention will undoubtedly suggest themselves tothose skilled in the art. Accordingly, the foregoing description shouldbe taken as illustrative and not in a limiting sense.

1. An instrument for remote placement of knots in a loop of suturehaving first and second ends extending through tissue and trimming ofsuture away from said knots comprising: a shaft having a distal end; adistal tip at said distal end having means for facilitating theformation of one or more knots in the suture extending from the tissue,in which said distal tip of said shaft when moved forward pushes saidformed knots for placement to the tissue; two openings at said distalend of said shaft through which is receivable two ends of the sutureextending from said placed knots; and means for cutting positionable tocut said suture extending through said openings.
 2. The instrumentaccording to claim 1 wherein said distal tip has a distal surfacecapable of facing tissue, and said means for facilitating the formationof one or more knots in the suture further comprises: a side cavity insaid distal tip; a hole extending from said distal surface of saiddistal tip to said cavity through which a first end of said suture isextendable.
 3. The instrument according to claim 2 wherein said hole issufficient large to enable passage of said first end of suture andsufficient small to prevent passage of any knot formed in said suturewhen said distal tip is pushed forward for placement of said formedknots to the tissue.
 4. The instrument according to claim 2 wherein saidmeans for facilitating the formation of one or more knots in the suturefurther comprises a tool having a loop extendable through said hole tosnare said first end of said suture and retractable to pull said firstend through said hole.
 5. The instrument according to claim 2 whereinsaid means for facilitating the formation of one or more knots in thesuture further comprises means for clamping tension to said first end ofsaid suture when extend through said hole to facilitate looping of saidsecond end of the suture by a user around said first end of said suturebetween said distal surface and the tissue to form said one or moreknots.
 6. The instrument according to claim 1 wherein said shaft has aproximal end, said instrument further comprising a housing at saidproximal end coupled to said shaft, and said cutting means furthercomprises: an actuator member pivotally mounted in said housing; amovable blade at said distal end of said shaft; and means for couplingsaid blade to said lever through said shaft to drive said blade from aretracted position to a forward position by pivoting said lever to cutsaid suture extending through said openings.
 7. The instrument accordingto claim 1 further comprising a tool having a loop extendable throughsaid two openings of said distal ends to snare the ends of said sutureextending from said placed knots and retractable to pull said first endof the suture through said two openings.
 8. The instrument according toclaim 1 wherein said two openings represent first and second openings,said distal tip has a distal surface capable of facing tissue, and saidmeans for facilitating the formation of one or more knots furthercomprises: a side cavity in said distal tip; a third opening extendingfrom said distal surface of said distal tip, and a passageway extendingfrom said third opening to said cavity, in which said first end of saidsuture is extendable through said third opening and said cavity via saidpassageway.
 9. The instrument according to claim 8 wherein said meansfor facilitating the formation of one or more knots in the suturefurther comprises a tool having a loop extendable through said cavityand third opening, via said passageway, to snare said first end of saidsuture and retractable to pull said first end of the suture through saidthird opening and cavity, via said passageway.
 10. The instrumentaccording to claim 8 wherein said means for facilitating the formationof one or more knots in the suture further comprising means for clampingsaid first end of said suture when extended through said third openingand cavity, via said passageway, to facilitate looping of said secondend of the suture by a user around said first end of said suture betweensaid distal surface and the tissue to form said one or more knots. 11.The instrument according to claim 8 wherein said passageway represents afirst passageway, and said distal tip further comprises: a fourthopening extending from said distal surface of said distal tip; a fifthopening along one side of said distal tip; a second passageway extendingfrom said fourth opening to said fifth opening; and a slot in saiddistal tip leading to said second passageway into which is receivablethe second end of said suture for passage through said second passagewaybetween said fourth and fifth openings.
 12. The instrument according toclaim 11 wherein said second end of said suture is received through saidslot into said second passageway between said fourth and fifth openingsafter said knots are formed, said second end of said suture is at leastpartially wrapped around the distal end of the shaft and clamped undertension while the first end of the suture is drawn through the firstpassageway as the distal end is pushed forward to place said formedknots to the tissue.
 13. The instrument according to claim 11 whereinsaid first passageway represents a non-open sided slot, and said secondpassageway represents an open-sided slot.
 14. A method for remoteplacement of knots and trimming of suture away from said knots from aloop of suture having first and second ends extending through tissueusing a single instrument, said method comprising the steps of: passinga distal end of the instrument into a body of a patient to locate saiddistal end near the tissue from which extends first and second ends ofsaid suture; locating the first end of the suture through a firstopening in the distal end of the instrument in which a cavity adjacentsaid first opening aids in passage of the first end of the suturethrough said opening; clamping the first end of the suture passedthrough said first opening; forming one or more knots with the secondend of said suture about said first end of the suture; advancing saiddistal end to said tissue to place said one or more knots adjacent thetissue while the first end of the suture is being drawn through saidfirst opening; unclamping said first end of the suture; removing saidfirst end of the suture from said first opening of said distal end;locating said first and second ends of the suture through second andthird openings in said distal end; moving said distal end adjacent tosaid one or more knots; and moving a blade at said distal end to cutsaid first and second ends of the suture located through said second andthird openings near said one or more knots.
 15. The method according toclaim 14 wherein said first opening represents one of a slot or hole.16. The method according to claim 14 wherein said method furthercomprises the steps of: locating said second end of said suture inanother opening at said distal end through a passageway open along oneside of the distal end prior to said advancing step being carried out;wrapping the second end of said suture extending from said passageway atleast partially around the distal end; and clamping the second end ofthe suture wrapped around the distal end under tension while saidadvancing step is carried out
 17. The method according to claim 14further comprising the step of imaging said distal end of theinstrument.
 18. A system for remote placement of knots in a loop ofsuture having first and second ends extending through tissue andtrimming suture away from said knots using a single instrument, saidsystem comprising: an instrument having a proximal end with a housing, ashaft extending from said housing to a distal end to enable remoteplacement of said distal end, a distal tip at said distal end having adistal surface capable of facing the tissue, said distal tip having oneor two passageways extending from said distal surface in which each ofsaid passageways extends through said distal tip to a different side ofsaid distal tip, in which the first end of said suture is extendablethrough one of said passageways to enable a user to loop the second endof said suture about the first end of said suture to form one or moreknots, and said distal tip when advanced places said one or more knotsadjacent the tissue while the first end of said suture is being drawnthrough said one of said passageways; said instrument having twoopenings at said distal end through which the first and second ends ofsaid suture are receivable through after placement of said one or moreknots to the tissue; and said instrument having a blade movable from aretracted position to a forward position to cut said suture extendingthrough said openings in which movement of said blade between saidretracted and forward positions is remotely controlled at said housing.19. The system according to claim 18 further comprising a second of saidpassageways open along one side of the distal end to receive the secondend of said suture in which the second end of the suture extending fromsaid second of said passageways is at least partially wrapped aroundsaid distal end of said shaft and clamped under tension when said distaltip is advanced to place said knot adjacent the tissue while the firstend of the suture is being drawn through said one of said passageways.20. The system according to claim 18 further comprising means forimaging the distal end of said instrument.
 21. An instrument for remoteplacement of one or more knots in the two ends of suture extending fromtissue, said instrument comprising: a shaft having a distal end; andsaid distal end having a front surface and a side surface with two slotsextending from said front surface to said side surface, in which one ofsaid slots is open along said side surface, and a different ones of saidends of said suture is receivable through different ones of said slots,when said one end of said suture is looped around the other end of saidsuture one or more times, and said distal end is advanced to said tissueto form said loops into one or more knots.
 22. The instrument accordingto claim 21 further comprising means at said distal end for cutting saidtwo ends of suture near said knots.
 23. A method for loading a knotpusher instrument with suture having two ends extending from tissue,said knot pusher having at least one hole or passageway for receivingsuture, said method comprising the steps of: inserting a loop of a toolthrough the hole or passageway of the knot pusher instrument; locatingone or both ends of the suture through said loop; retracting said loopthrough the hole or passageway; and releasing said end of suture fromsaid loop to leave the suture through said hole or passageway.
 24. Amethod for forming a knot in two ends of suture extending from a tissuewound site comprising the steps of: placing a first end of the suturethrough a hole or passageway along a distal end of an instrument;wrapping the second end of the suture around the first end of the sutureto form a double loop between the distal end of the instrument and thewound site; wrapping the second end of the suture around the first endof the suture to form a single loop between the distal end of theinstrument and the double loop; pulling the first end of the suture awayfrom the wound site while advancing the instrument to push the withouttension of the second end of the suture to form a knot from the doubleloop and the single loop adjacent the wound site; and pulling of thesecond end of the suture to cause the double loop and the single loop ofsuture to lock the knot adjacent the wound site.